Release – SKYX Announces a Collaboration with Home Depot for its Advanced and Smart Plug & Play Products for both Retail and Professional Segments

Research News and Market Data on SKYX

SKYX will Offer a Variety of its Advanced and Smart Plug & Play Products including Retrofit Kits, Smart Light Fixtures, Smart Ceiling Fans, Ceiling Outlet Receptacles, Recessed Lights and More

MIAMI, July 30, 2024 (GLOBE NEWSWIRE) — SKYX (NASDAQ: SKYX) (d/b/a “SKYX Technologies”), a highly disruptive smart platform technology company with over 94 issued and pending patents in the U.S. and globally, and which owns over 60 lighting and home décor websites with a mission to make homes and buildings become smart, safe, and advanced as the new standard, announced today a collaboration with world leading home improvement retailer, Home Depot, for its advanced and smart plug & play products.

SKYX will offer a variety of its Advanced and Smart Plug & Play Products including Retrofit Kits, Smart Light Fixtures, Smart Ceiling Fans, Ceiling Outlet Receptacles, and Recessed Lights among others. A large assortment of these advanced and smart products is expected to be offered on Home Depot’s website in the next coming months, while some advanced and smart plug & play retrofit kit products are expected to arrive in select stores and online to be offered as a fixture upgrade.

Steve Schmidt President of SKYX Platform said: “We are truly excited that we are collaborating with the world leading home improvement company Home Depot. Our technology offers a variety of products for both retail and professional segments; therefore, I view this collaboration as a tremendous growth opportunity for us that can have a significant impact on our business”.

Rani Kohen, Founder and Executive Chairman of SKYX Platforms, said: “We are excited to work together with Home Depot, a global leader in retail and professional industries. We strongly believe that this opportunity will have a significant effect on our business and market penetration for both our retail and professional sales channels”.

About SKYX Platforms Corp.

As electricity is a standard in every home and building, our mission is to make homes and buildings become safe-advanced and smart as the new standard. SKYX has a series of highly disruptive advanced-safe-smart platform technologies, with over 94 U.S. and global patents and patent pending applications. Additionally, the Company owns over 60 lighting and home decor websites for both retail and commercial segments. Our technologies place an emphasis on high quality and ease of use, while significantly enhancing both safety and lifestyle in homes and buildings. We believe that our products are a necessity in every room in both homes and other buildings in the U.S. and globally. For more information, please visit our website at https://skyplug.com/ or follow us on LinkedIn.

Forward-Looking Statements

Certain statements made in this press release are not based on historical facts, but are forward-looking statements. These statements can be identified by the use of forward-looking terminology such as “aim,” “anticipate,” “believe,” “can,” “could,” “continue,” “estimate,” “expect,” “evaluate,” “forecast,” “guidance,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “outlook,” “plan,” “potential,” “predict,” “probable,” “project,” “seek,” “should,” “target” “view,” “will,” or “would,” or the negative thereof or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements reflect the Company’s reasonable judgment with respect to future events and are subject to risks, uncertainties and other factors, many of which have outcomes difficult to predict and may be outside our control, that could cause actual results or outcomes to differ materially from those in the forward-looking statements. Such risks and uncertainties include statements relating to the Company’s ability to successfully launch, commercialize, develop additional features and achieve market acceptance of its products and technologies and integrate its products and technologies with third-party platforms or technologies; the Company’s efforts and ability to drive the adoption of its products and technologies as a standard feature, including their use in homes, hotels, offices and cruise ships; the Company’s ability to capture market share; the Company’s estimates of its potential addressable market and demand for its products and technologies; the Company’s ability to raise additional capital to support its operations as needed, which may not be available on acceptable terms or at all; the Company’s ability to continue as a going concern; the Company’s ability to execute on any sales and licensing or other strategic opportunities; the possibility that any of the Company’s products will become National Electrical Code (NEC)-code or otherwise code mandatory in any jurisdiction, or that any of the Company’s current or future products or technologies will be adopted by any state, country, or municipality, within any specific timeframe or at all; risks arising from mergers, acquisitions, joint ventures and other collaborations; the Company’s ability to attract and retain key executives and qualified personnel; guidance provided by management, which may differ from the Company’s actual operating results; the potential impact of unstable market and economic conditions on the Company’s business, financial condition, and stock price; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including its periodic reports on Form 10-K and Form 10-Q. There can be no assurance as to any of the foregoing matters. Any forward-looking statement speaks only as of the date of this press release, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by U.S. federal securities laws.

Investor Relations Contact:

Jeff Ramson

PCG Advisory

jramson@pcgadvisory.com

Release – Schwazze Sets Second Quarter 2024 Conference Call for August 13, 2024 at 5:00 P.M. ET

Research News and Market Data on SHWZ

DENVER, July 30, 2024 (GLOBE NEWSWIRE) — Medicine Man Technologies, Inc., operating as Schwazze, (OTC: SHWZ) (Cboe CA: SHWZ) (“Schwazze” or the “Company”), will host a conference call on Tuesday, August 13, 2024 at 5:00 p.m. Eastern time to discuss its financial and operational results for the second quarter ended June 30, 2024. The Company’s results will be reported in a press release prior to the call.

The Schwazze management team will host the conference call, followed by a question-and-answer period. Interested parties may submit questions to the Company prior to the call by emailing ir@schwazze.com.

Date: Tuesday, August 13, 2024
Time: 5:00 p.m. Eastern time
Toll-free dial-in: (844) 825-9789
International dial-in: (412) 317-5180
Conference ID: 10191294
Webcast: SHWZ Q2 2024 Earnings Call

The conference call will also be broadcast live and available for replay on the investor relations section of the Company’s website at https://ir.schwazze.com.

Toll-free replay number: (844) 512-2921
International replay number: (412) 317-6671
Replay ID: 10191294

If you have any difficulty registering or connecting with the conference call, please contact Elevate IR at (720) 330-2829.

About Schwazze

Schwazze (OTC: SHWZ) (Cboe CA: SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale.

Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector.

Medicine Man Technologies, Inc. was Schwazze’s former operating trade name. The corporate entity continues to be named Medicine Man Technologies, Inc. Schwazze derives its name from the pruning technique of a cannabis plant to enhance plant structure and promote healthy growth. To learn more about Schwazze, visit http://www.schwazze.com/.

Investor Relations Contact

Sean Mansouri, CFA or Aaron D’Souza
Elevate IR
(720) 330-2829
ir@schwazze.com

US National Debt Hits $35 Trillion: Implications and Challenges

Key Points:
– US national debt surpasses $35 trillion, growing at nearly $5 billion per day in 2025.
– Debt-to-GDP ratio reaches 120%, highest since World War II.
– Interest payments on debt now exceed defense spending.
– Political attention to the debt crisis remains limited despite its significance.

The United States has crossed a critical financial threshold as its national debt surpassed $35 trillion, according to recent Treasury Department reports. This unprecedented figure represents more than just a number; it signifies a complex economic challenge with far-reaching implications for the nation’s future, its global standing, and the financial well-being of every American citizen.

The pace of debt accumulation is alarming. Since January, the national debt has increased by $1 trillion, growing at a rate of nearly $5 billion per day in 2025. This rapid expansion has pushed the debt-to-GDP ratio to 120%, a level not seen since the aftermath of World War II. Projections from the Congressional Budget Office suggest this ratio could reach a staggering 166% by 2054 if current trends continue.

The roots of this debt crisis stretch back decades but have accelerated dramatically in recent years. Both the Trump and Biden administrations have overseen significant increases, with the debt jumping by more than 75% during their combined terms. The COVID-19 pandemic exacerbated the situation, necessitating unprecedented levels of government spending to stabilize the economy.

One of the most concerning aspects of this debt milestone is the cost of servicing it. Interest payments on the national debt have now surpassed defense spending, creating a significant drain on the federal budget. This situation threatens to crowd out funding for essential government services and investments in the nation’s future.

Despite the gravity of the situation, the issue has received surprisingly little attention in the ongoing 2024 presidential campaign. Neither presumptive Democratic nominee Vice President Kamala Harris nor former President Donald Trump have offered substantial plans to address the debt crisis. In fact, both parties are considering policies that could potentially worsen the situation, such as extending tax cuts set to expire in 2025.

The lack of political focus on this issue is particularly troubling given the looming tax debate. The expiration of major provisions from the 2017 Trump tax cuts at the end of 2025 presents both a challenge and an opportunity. Extending these cuts without offsets could add trillions more to the national debt, while allowing them to expire would effectively raise taxes on many Americans.

Economic experts and fiscal responsibility advocates are sounding the alarm. Maya MacGuineas, president of the Committee for a Responsible Federal Budget, described the situation as “reckless and unyielding,” warning that the risks and warning signs seem to be falling on deaf ears in Washington.

The implications of this debt level extend far beyond the realm of fiscal policy. High national debt can lead to reduced economic growth, lower living standards, and diminished global influence. It also leaves the country more vulnerable to economic shocks and less able to respond to future crises.

As the United States grapples with this historic debt level, it’s clear that addressing the issue will require difficult choices and bipartisan cooperation. Potential solutions may include a combination of spending cuts, revenue increases, and economic growth strategies. However, any approach will likely involve trade-offs and sacrifices that may be politically unpopular.

The $35 trillion national debt milestone serves as a stark reminder of the fiscal challenges facing the United States. As the 2024 election approaches, voters and policymakers alike must grapple with this issue and its long-term implications for America’s economic future and global standing. The decisions made in the coming years will play a crucial role in determining whether the United States can reverse this trend and ensure a sustainable fiscal path for future generations.

Xcel Brands (XELB) – A Set Up For 2025


Tuesday, July 30, 2024

Xcel Brands, Inc. 1333 Broadway 10th Floor New York, NY 10018 United States https:/Sector(s): Consumer Cyclical Industry: Apparel Manufacturing Full Time Employees: 84 Key Executives Name Title Pay Exercised Year Born Mr. Robert W. D’Loren Chairman, Pres & CEO 1.27M N/A 1958 Mr. James F. Haran CFO, Principal Financial & Accou

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

In line Q2 preliminary results. The company announced limited, preliminary operating results from Q2. Revenue in the quarter is expected to be $3.0 million, modestly below our estimate of $3.6 million, and adj. EBITDA of negative $40,000 was in line with our estimate of negative $64,000. 

LOGO sale finalized. The sale of the LOGO brand was finalized on June 30, and the company is expected to recognized a one time gain of $3.8 million. We estimate that Lori Goldstein accounted for roughly $5 million in annual revenues and $2 million in adj. EBITDA. However, after earn-outs, we estimate that the company was losing money on the brand.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Eledon Pharmaceuticals (ELDN) – Eledon Announces Patient Enrollment Milestone and Confirms Timeframe For Completion


Tuesday, July 30, 2024

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Eledon Announced It Has Reached Two-Thirds Patient Enrollment Milestone. Eledon has enrolled its 80th patient in the Phase 2 BESTOW trial testing tegoprubart against tacrolimus for prevention of kidney transplant rejection. The trial is expected to reach its full enrollment of 120 patients by YE2024 as expected.

The BESTOW Trial Is Designed To Compare Tegoprubart To Tacrolimus. The Phase 2 BESTOW trial is an open-label active-comparator trial comparing tegoprubart directly against tacrolimus, the standard of care in kidney transplantation. The primary endpoint is superior mean eGFR (a measure of kidney graft function) at 12 months post-transplant, with additional endpoints to provide clinically meaningful measures for comparison with tacrolimus.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Lundin Mining and BHP’s Joint Venture: Reshaping the Copper Mining Landscape

Key Points:
– Lundin Mining and BHP form a C$4.1 billion joint venture to acquire Filo Corp.
– The deal focuses on developing the Filo del Sol and Josemaria copper projects in the Vicuña District.
– This transaction reflects industry trends towards consolidation, copper focus, and long-term district-scale development.

The recent announcement of Lundin Mining and BHP’s joint acquisition of Filo Corp. and the formation of a 50/50 joint venture marks a significant milestone in the global mining industry, particularly in the copper sector. This C$4.1 billion deal, valuing Filo at C$33.00 per share, represents a strategic move to consolidate and develop one of the world’s most promising copper districts. At the heart of this transaction are two key projects: the Filo del Sol (FDS) copper-gold-silver deposit and the Josemaria copper project, located along the Argentina-Chile border. Together, these projects form part of the emerging Vicuña District, which has the potential to become one of the world’s largest copper mining complexes.

The deal structure is multifaceted, with Lundin Mining and BHP jointly acquiring Filo Corp. Filo shareholders have the option to receive cash, Lundin Mining shares, or a combination thereof. Concurrently, BHP will pay Lundin Mining US$690 million for a 50% stake in the Josemaria project, forming a joint venture that will control both FDS and Josemaria.

This transaction offers valuable insights into the current state and future direction of the mining sector. It exemplifies the ongoing trend of consolidation in the industry, particularly in copper mining. As easily accessible deposits become scarcer, major players are joining forces to tackle more challenging, but potentially more rewarding, projects. The significant premium paid for Filo Corp. underscores the growing importance of copper in the global economy, with the metal playing a crucial role in renewable energy and electric vehicle technologies.

The joint venture’s focus on developing the entire Vicuña District, rather than individual projects, reflects a shift towards more comprehensive, long-term approaches in mining. This strategy allows for greater operational synergies and more efficient use of infrastructure. By partnering, Lundin Mining and BHP are effectively sharing both the risks and rewards of these large-scale projects. BHP brings its extensive experience in developing major mining operations, while Lundin Mining contributes its regional expertise and the advanced stage of the Josemaria project.

The commitment to develop the projects “in accordance with sound mining principles consistent with international industry standards” highlights the increasing importance of environmental, social, and governance (ESG) factors in mining operations. This focus on sustainability and responsible mining practices is becoming a key consideration for investors and stakeholders in the industry.

The location of these projects in Argentina and Chile underscores the continued importance of South America in global copper production, despite recent political uncertainties in some countries in the region. With the potential for a “multi-generational mining district,” this deal reflects a long-term outlook in the mining sector, looking beyond current market conditions to secure resources for future decades.

As the global demand for copper continues to grow, driven by green energy transitions and technological advancements, deals of this magnitude and strategic importance are likely to become more common. The success of this joint venture could set a precedent for future partnerships in the industry, as companies seek to balance the immense capital requirements and risks associated with developing world-class deposits against the potential long-term rewards.

The mining sector, particularly in copper, is clearly entering a new era characterized by larger, more complex projects that require collaboration among major players. This deal between Lundin Mining and BHP could reshape the landscape of the global mining industry in the years to come, potentially inspiring similar collaborations and strategic partnerships. As the world increasingly turns to electrification and renewable energy, the importance of securing and developing large-scale copper resources will only continue to grow, making deals like this one crucial for meeting future global demand.

Crypto’s Political Surge: A New Frontier for Investors in the 2024 Election Landscape

Key Points:
– Political attention on cryptocurrency is growing, potentially influencing future regulations and market dynamics.
-Trump and other politicians are making pro-crypto promises, but implementation challenges remain.
– Investors should watch for policy shifts that could impact crypto markets and related investments.

As the 2024 U.S. presidential election looms, cryptocurrency has unexpectedly taken center stage, promising to reshape both the political and investment landscapes. The recent Bitcoin 2024 conference in Nashville served as a lightning rod for political attention, with figures from across the spectrum – most notably former President Donald Trump – making bold commitments to the crypto community.

Trump’s promises were sweeping: appointing a crypto Presidential Advisory Council, ousting SEC chair Gary Gensler, introducing crypto-friendly regulations, and even establishing a “strategic national bitcoin stockpile.” These pledges were echoed and amplified by other politicians, including Senator Cynthia Lummis and independent candidate Robert F. Kennedy Jr., who proposed acquiring up to 4 million bitcoins for a national reserve.

For investors, this surge in political interest signals potential seismic shifts in the regulatory environment. However, it’s crucial to approach these promises with a healthy dose of skepticism. Many proposed actions face significant legislative and legal hurdles, even in a favorable political climate.

The crypto industry’s growing political clout is evident in its fundraising prowess. FairShake, the largest crypto Super PAC, has amassed over $200 million, positioning itself as a formidable force in upcoming elections. This financial muscle could translate into increased lobbying power and potentially more favorable policies for the sector.

From an investment perspective, this political momentum could lead to several outcomes:

  1. Regulatory Clarity: A pro-crypto administration could usher in clearer regulations, potentially reducing market uncertainty and attracting more institutional investors.
  2. Market Volatility: Political developments will likely trigger significant price movements, creating both opportunities and risks for traders and investors.
  3. Mainstream Adoption: Increased political legitimacy could accelerate crypto’s integration into traditional financial systems, opening new investment avenues.
  4. Sectoral Impact: Companies in blockchain technology, cybersecurity, and fintech could see increased interest as crypto gains political traction.
  5. Global Competition: A U.S. pivot towards crypto-friendly policies could influence global crypto regulations and investments.

However, investors should remain cautious. The crypto market’s notorious volatility persists, and political promises often face significant obstacles in implementation. The recent ascension of Vice President Kamala Harris as the presumptive Democratic nominee adds another layer of uncertainty, given her undeclared stance on crypto regulation.

Bitcoin’s price action following the conference – surging above $70,000 before retreating – underscores the market’s sensitivity to political developments. Year-to-date, Bitcoin has risen over 50%, buoyed by increased institutional interest following the launch of Bitcoin ETFs.

As the election approaches, savvy investors should monitor several key areas:

  1. Proposed legislation affecting crypto regulations
  2. Appointments to key regulatory positions, especially at the SEC and CFTC
  3. Statements from major political figures on crypto policy
  4. Progress on initiatives like a national bitcoin reserve
  5. International reactions and policy shifts in response to U.S. developments

While political attention on crypto is growing, it’s important to note that widespread adoption and understanding remain limited. As Trump candidly observed, “most people have no idea what the hell it is.” This gap between political rhetoric and public comprehension presents both challenges and opportunities for investors.

For those considering crypto investments, a multifaceted approach is crucial:

  1. Diversification: Balance crypto investments with traditional assets to manage risk.
  2. Due Diligence: Thoroughly research projects and platforms before investing.
  3. Regulatory Awareness: Stay informed about evolving regulations both domestically and internationally.
  4. Technology Understanding: Grasp the underlying technology and its potential applications beyond currency.
  5. Long-term Perspective: Consider the long-term potential of blockchain technology beyond short-term price fluctuations.

As the 2024 election unfolds, the interplay between politics, regulation, and crypto markets will likely intensify. For investors, this evolving landscape presents a unique set of opportunities and risks. Those who can navigate the complex intersection of technology, finance, and politics may find themselves well-positioned in this new frontier of investing.

Remember, while the potential for high returns exists, so too does the risk of significant losses. As always, it’s crucial to approach any investment, especially in the volatile crypto space, with caution and in alignment with one’s risk tolerance and financial goals.

Release – FreightCar America, Inc. To Release Second Quarter Results On August 12, 2024

Research News and Market Data on RAIL

CHICAGO, July 29, 2024 (GLOBE NEWSWIRE) — FreightCar America, Inc. (NASDAQ: RAIL), a diversified manufacturer of railroad freight cars, today announced that it will release its second quarter 2024 financial results on Monday, August 12, 2024 after the market close. The conference call and live webcast will be held on Tuesday, August 13 at 11:00 a.m. (Eastern Time), and will be available on the Investor Relations page of the Company’s website at www.freightcaramerica.com.

Investors, analysts, and members of the media interested in listening to the live presentation are encouraged to join a webcast of the call which can be accessed at:

Event URL: https://viavid.webcasts.com/starthere.jsp?ei=1678919&tp_key=7f0a694b35

Please note that the webcast is listen-only and webcast participants will not be able to participate in the question and answer portion of the conference call. Interested parties may also participate in the call by dialing (877) 407-0789 or (201) 689-8562. Interested parties are asked to dial in approximately 10 to 15 minutes prior to the start time of the call.

An audio replay of the conference call will be available beginning at 3:00 p.m. (Eastern Time) on Tuesday, August 13, 2024, until 11:59 p.m. (Eastern Time) on Tuesday, August 27, 2024. To access the replay, please dial (844) 512-2921 or (412) 317-6671. The replay passcode is 13747591. An archived version of the webcast will also be available on the FreightCar America Investor Relations website.

About FreightCar America

FreightCar America, headquartered in Chicago, Illinois, is a leading designer, producer and supplier of railroad freight cars, railcar parts and components. We also specialize in railcar repairs, complete railcar rebody services and railcar conversions that repurpose idled rail assets back into revenue service. Since 1901, our customers have trusted us to build quality railcars that are critical to economic growth and instrumental to the North American supply chain. To learn more about FreightCar America, visit www.freightcaramerica.com.

Investor ContactRAILIR@Riveron.com

Source: FreightCar America, Inc.

Release – FAT Brands to Announce Second Quarter 2024 Financial Results On July 31, 2024

Research News and Market Data on FAT

LOS ANGELES, July 29, 2024 (GLOBE NEWSWIRE) — FAT (Fresh. Authentic. Tasty.) Brands Inc. (NASDAQ: FAT) (“FAT Brands” or the “Company”), a leading global franchising company and parent company of iconic brands including Round Table Pizza, Fatburger, Johnny Rockets, Twin Peaks, Fazoli’s and 13 other restaurant concepts, today announced that the Company will host a conference call to review its second quarter 2024 financial results on Wednesday, July 31, 2024 at 5:00 PM ET. A press release with second quarter 2024 financial results will be issued prior to the conference call that day.

The conference call can be accessed live over the phone by dialing 1-844-826-3035 from the U.S. or 1-412-317-5195 internationally. A replay will be available after the call until Wednesday, August 31, 2024, and can be accessed by dialing 1-844-512-2921 from the U.S. or 1-412-317-6671 internationally. The passcode is 10189773. Hosting the call will be Andy Wiederhorn, Chairman, and Ken Kuick, Co-Chief Executive Officer and Chief Financial Officer.

The conference call will also be webcast live from the corporate website at www.fatbrands.com, under the “Investors” section. A replay of the webcast will be available through the corporate website shortly after the call has concluded.

About FAT (Fresh. Authentic. Tasty.) Brands

FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets, and develops fast casual, quick-service, casual dining, and polished casual dining concepts around the world. The Company currently owns 18 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Smokey Bones, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Pretzelmaker, Elevation Burger, Native Grill & Wings, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide. For more information on FAT Brands, please visit www.fatbrands.com.

Investor Relations:
ICR
Michelle Michalski
IR-FATBrands@icrinc.com
646-277-1224

Media Relations:
Erin Mandzik
emandzik@fatbrands.com
860-212-6509

Release – Eledon Provides Enrollment Update for Phase 2 BESTOW Trial Assessing Tegoprubart for the Prevention of Organ Rejection

July 29, 2024

80 Participants (Two-thirds of Projected Recruitment) Enrolled

IRVINE, Calif., July 29, 2024 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that it has enrolled the 80th participant in its ongoing Phase 2 BESTOW trial assessing tegoprubart for the prevention of rejection in kidney transplantation.

“As of this week, we have already enrolled two-thirds of the projected study participants across sites in the United States, Europe and Latin America,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “We are grateful to the participants and their clinical teams, whose high level of interest enabled us to achieve this level of enrollment in our Phase 2 BESTOW trial. This progress underscores the urgency and need for innovative solutions in preventing kidney transplant rejection. We remain on track to complete enrollment by the end of the year.”

BESTOW, a multicenter, two-arm, active comparator clinical study, will enroll approximately 120 participants undergoing kidney transplantation in the United States, Europe and Latin America to evaluate the safety, pharmacokinetics, and efficacy of the anti-CD40 ligand antibody tegoprubart compared to the calcineurin inhibitor tacrolimus. The study’s primary objective is to assess graft function at 12 months post-transplant, as measured by estimated glomerular filtration rate (eGFR), in participants treated with tegoprubart compared to tacrolimus. Better graft function as assessed by eGFR has been associated with improved long-term patient and graft survival.

Eledon is currently conducting a Phase 2 trial (BESTOW; NCT05983770), a Phase 1b trial (NCT05027906), and a long-term safety and efficacy extension study (NCT06126380) to evaluate tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedInTwitter

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, expected or future results of tegoprubart trials and its ability to prevent rejection in connection with kidney transplantation, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sites, as well as patient enrollment; and risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com

Source: Eledon Pharmaceuticals

Primary Logo

Source: Eledon Pharmaceuticals, Inc.

Release – CORRECTING and REPLACING Alliance Resource Partners, L.P. Reports Second Quarter Financial and Operating Results; Declares Quarterly Cash Distribution of $0.70 Per Unit and Updates 2024 Guidance

Research News and Market Data on ARLP

July 29, 2024

Download(opens in new window)

2024 Quarter Highlights

  • Second quarter 2024 total revenue of $593.4 million, net income of $100.2 million, and EBITDA of $177.7 million
  • Coal sales price realizations of $65.30 per ton sold, up 3.8% year-over-year
  • Increased oil & gas royalty volumes to 817 MBOE, up 6.8% year-over-year
  • In June 2024, issued $400 million in 8.625% Senior Notes due 2029 and redeemed outstanding balance of Senior Notes due 2025
  • Extended revolving credit facility maturity to March 2028
  • Enhanced liquidity position to $666.0 million, which included $203.7 million in cash and $462.3 million of borrowings available under credit facilities
  • In July 2024, declared quarterly cash distribution of $0.70 per unit, or $2.80 per unit annualized

TULSA, Okla.–(BUSINESS WIRE)– In the Condensed Consolidated Statements of Income and Operating Data table the figure for INCOME FROM OPERATIONS for the Three Months Ended June 2023 should read: 183,929 (instead of 10183,929).

The updated release reads:

ALLIANCE RESOURCE PARTNERS, L.P. REPORTS SECOND QUARTER FINANCIAL AND OPERATING RESULTS; DECLARES QUARTERLY CASH DISTRIBUTION OF $0.70 PER UNIT AND UPDATES 2024 GUIDANCE

2024 Quarter Highlights

  • Second quarter 2024 total revenue of $593.4 million, net income of $100.2 million, and EBITDA of $177.7 million
  • Coal sales price realizations of $65.30 per ton sold, up 3.8% year-over-year
  • Increased oil & gas royalty volumes to 817 MBOE, up 6.8% year-over-year
  • In June 2024, issued $400 million in 8.625% Senior Notes due 2029 and redeemed outstanding balance of Senior Notes due 2025
  • Extended revolving credit facility maturity to March 2028
  • Enhanced liquidity position to $666.0 million, which included $203.7 million in cash and $462.3 million of borrowings available under credit facilities
  • In July 2024, declared quarterly cash distribution of $0.70 per unit, or $2.80 per unit annualized

Alliance Resource Partners, L.P. (NASDAQ: ARLP) (“ARLP” or the “Partnership”) today reported financial and operating results for the three and six months ended June 30, 2024 (the “2024 Quarter” and “2024 Period,” respectively). This release includes comparisons of results to the three and six months ended June 30, 2023 (the “2023 Quarter” and “2023 Period,” respectively) and to the quarter ended March 31, 2024 (the “Sequential Quarter”). All references in the text of this release to “net income” refer to “net income attributable to ARLP.” For a definition of EBITDA and related reconciliation to its comparable GAAP financial measure, please see the end of this release.

Total revenues in the 2024 Quarter decreased 7.6% to $593.4 million compared to $641.8 million for the 2023 Quarter primarily as a result of reduced coal sales volumes, which declined 11.8% primarily due to transportation delays, partially offset by increased coal sales price realizations, which rose 3.8% to $65.30 per ton sold in the 2024 Quarter compared to $62.93 per ton sold in the 2023 Quarter. Net income for the 2024 Quarter was $100.2 million, or $0.77 per basic and diluted limited partner unit, compared to $169.8 million, or $1.30 per basic and diluted limited partner unit, for the 2023 Quarter as a result of lower revenues and increased total operating expenses. EBITDA for the 2024 Quarter was $177.7 million compared to $249.2 million in the 2023 Quarter.

Compared to the Sequential Quarter, total revenues in the 2024 Quarter decreased 9.0% primarily as a result of lower tons sold. Lower revenues and a $3.7 million reduction in the fair value of our digital assets, partially offset by reduced operating expenses, reduced net income and EBITDA by 36.6% and 24.4%, respectively, compared to the Sequential Quarter.

Total revenues decreased 4.6% to $1.25 billion for the 2024 Period compared to $1.30 billion for the 2023 Period primarily due to lower coal sales, partially offset by higher oil & gas royalties and other revenues. Net income for the 2024 Period was $258.2 million, or $1.98 per basic and diluted limited partner unit, compared to $361.0 million, or $2.75 per basic and diluted limited partner unit, for the 2023 Period as a result of lower revenues and increased total operating expenses. EBITDA for the 2024 Period was $412.7 million compared to $520.1 million in the 2023 Period.

CEO Commentary

“During the 2024 Quarter we enhanced our liquidity position,” highlighted Joseph W. Craft III, Chairman, President, and Chief Executive Officer. “The successful completion of our Senior Notes offering further strengthened our balance sheet and represents a vote of confidence from the capital markets for our business strategy and plans for execution. As we have said time and again, reliable, affordable, baseload energy is a cornerstone of our nation’s economy, and our strong financial position means we are well-positioned to provide strategic energy supply from our well-capitalized and strategically located coal mines and growing minerals acreage portfolio for many years to come.”

“Coal sales volumes during the 2024 Quarter were impacted by flooding on the Ohio River delaying barge deliveries. Rail and port logistics were disrupted by the Baltimore bridge incident, which as time progressed impacted shipments from our Appalachia rail operations. These delays, combined with lower export sales, lifted our inventories higher by 0.8 million tons compared to the Sequential Quarter,” commented Mr. Craft. “Our well-contracted order book continued to provide stability for our business, delivering improvements in coal sales pricing per ton compared to both the 2023 Quarter and the Sequential Quarter. Additionally, our Oil & Gas Royalties segment reported a 6.8% increase in BOE volumes year-over-year during the 2024 Quarter as our Permian-weighted minerals portfolio continues to realize production growth from recently drilled and completed wells.”

Balance Sheet and Liquidity

As of June 30, 2024, total debt and finance leases outstanding were $503.9 million, including $400 million in newly issued Senior Notes due 2029. The Partnership’s total and net leverage ratios were 0.61 times and 0.36 times debt to trailing twelve months Adjusted EBITDA, respectively, as of June 30, 2024. ARLP ended the 2024 Quarter with total liquidity of $666.0 million, which included $203.7 million of cash and cash equivalents and $462.3 million of borrowings available under its revolving credit and accounts receivable securitization facilities.

During the 2024 Quarter, the Partnership issued $400 million in 8.625% Senior Notes due 2029 and redeemed the outstanding balance of $284.6 million in ARLP’s 7.5% Senior Notes due 2025. The Partnership also amended its revolving credit facility to extend the maturity date to March 9, 2028.

Distributions

On July 26, 2024, we announced that the Board of Directors of ARLP’s general partner (the “Board”) approved a cash distribution to unitholders for the 2024 Quarter of $0.70 per unit (an annualized rate of $2.80 per unit), payable on August 14, 2024, to all unitholders of record as of the close of trading on August 7, 2024. The announced distribution is consistent with the cash distributions for the 2023 Quarter and Sequential Quarter.

Outlook

“For the first half of 2024, utility coal burn has been essentially flat with 2023,” commented Mr. Craft. “Since the start of this summer, cooling demand has been strong across many parts of the country driven by recent record-breaking temperatures and accelerating coal-based power generation. This is encouraging considering the very mild 2024 winter and persistently low natural gas prices. At the same time, while demand is holding up, U.S. thermal coal production has slowed significantly (Eastern U.S. production down 11% year-over-year) as utilities are relying on consuming coal from their elevated inventories to meet this demand. Weather forecasts suggest this heat wave will continue through August and an industry publication is projecting demand will exceed supply by close to 20 million tons in the second half of 2024.”

“Turning to the export markets, net back pricing for high sulfur Illinois Basin coal has declined to a level that we have decided it is prudent to slow down production for the back half of the year. Therefore, we are adjusting 2024 full-year guidance for our coal operations. At the midpoint, we now expect to sell approximately 34.0 million tons in 2024, or 2.6% below the mid-point of our original guidance for the year. Due to the increased summer burn, we now expect more than half of our uncontracted tonnage position will be sold in the domestic market.”

Mr. Craft continued, “Looking at our Oil & Gas Royalties platform, year-to-date performance and continued strong activity across our Permian Basin acreage has set the tone for another robust year. As a result, we are pleased to increase volumetric guidance across all three commodity streams within our Oil & Gas Royalties segment.”

Mr. Craft concluded, “The increase in coal-fired generation and inventory drawdown is constructive for the U.S. thermal coal market and for ARLP as we look forward to next year and beyond. We remain confident in the core fundamentals expected to drive rapid growth in electricity demand for many years to come, including the increasing power requirements stemming from AI, data centers, and the onshoring of U.S. manufacturing.”

Conference Call

A conference call regarding ARLP’s 2024 Quarter financial results is scheduled for today at 10:00 a.m. Eastern. To participate in the conference call, dial (877) 407-0784 and request to be connected to the Alliance Resource Partners, L.P. earnings conference call. International callers should dial (201) 689-8560 and request to be connected to the same call. Investors may also listen to the call via the “Investors” section of ARLP’s website at www.arlp.com .

An audio replay of the conference call will be available for approximately one week. To access the audio replay, dial U.S. Toll Free (844) 512-2921; International Toll (412) 317-6671 and request to be connected to replay using access code 13747640.

About Alliance Resource Partners, L.P.

ARLP is a diversified energy company that is currently the largest coal producer in the eastern United States, supplying reliable, affordable energy domestically and internationally to major utilities, metallurgical and industrial users. ARLP also generates operating and royalty income from mineral interests it owns in strategic coal and oil & gas producing regions in the United States. In addition, ARLP is evolving and positioning itself as a reliable energy partner for the future by pursuing opportunities that support the advancement of energy and related infrastructure.

News, unit prices and additional information about ARLP, including filings with the Securities and Exchange Commission (“SEC”), are available at www.arlp.com . For more information, contact the investor relations department of ARLP at (918) 295-7673 or via e-mail at investorrelations@arlp.com .

The statements and projections used throughout this release are based on current expectations. These statements and projections are forward-looking, and actual results may differ materially. These projections do not include the potential impact of any mergers, acquisitions or other business combinations that may occur after the date of this release. We have included more information below regarding business risks that could affect our results.

FORWARD-LOOKING STATEMENTS: With the exception of historical matters, any matters discussed in this press release are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from projected results. Those forward-looking statements include expectations with respect to our future financial performance, coal and oil & gas consumption and expected future prices, our ability to increase unitholder distributions in future quarters, business plans and potential growth with respect to our energy and infrastructure transition investments, optimizing cash flows, reducing operating and capital expenditures, infrastructure projects at our existing properties, growth in domestic electricity demand, preserving liquidity and maintaining financial flexibility, and our future repurchases of units and senior notes, among others. These risks to our ability to achieve these outcomes include, but are not limited to, the following: decline in the coal industry’s share of electricity generation, including as a result of environmental concerns related to coal mining and combustion, the cost and perceived benefits of other sources of electricity and fuels, such as oil & gas, nuclear energy, and renewable fuels and the planned retirement of coal-fired power plants in the U.S.; our ability to provide fuel for growth in domestic energy demand, should it materialize; changes in macroeconomic and market conditions and market volatility, and the impact of such changes and volatility on our financial position; changes in global economic and geo-political conditions or changes in industries in which our customers operate; changes in commodity prices, demand and availability which could affect our operating results and cash flows; the outcome or escalation of current hostilities in Ukraine and the Israel-Gaza conflict; the severity, magnitude and duration of any future pandemics and impacts of such pandemics and of businesses’ and governments’ responses to such pandemics on our operations and personnel, and on demand for coal, oil, and natural gas, the financial condition of our customers and suppliers and operators, available liquidity and capital sources and broader economic disruptions; actions of the major oil-producing countries with respect to oil production volumes and prices could have direct and indirect impacts over the near and long term on oil & gas exploration and production operations at the properties in which we hold mineral interests; changes in competition in domestic and international coal markets and our ability to respond to such changes; potential shut-ins of production by the operators of the properties in which we hold oil & gas mineral interests due to low commodity prices or the lack of downstream demand or storage capacity; risks associated with the expansion of and investments into the infrastructure of our operations and properties; our ability to identify and complete acquisitions and to successfully integrate such acquisitions into our business and achieve the anticipated benefits therefrom; our ability to identify and invest in new energy and infrastructure transition ventures; the success of our development plans for our wholly owned subsidiary, Matrix Design Group, LLC, and our investments in emerging infrastructure and technology companies; dependence on significant customer contracts, including renewing existing contracts upon expiration; adjustments made in price, volume, or terms to existing coal supply agreements; the effects of and changes in trade, monetary and fiscal policies and laws, central bank policy actions including interest rates, bank failures and associated liquidity risks; the effects of and changes in taxes or tariffs and other trade measures adopted by the United States and foreign governments; legislation, regulations, and court decisions and interpretations thereof, both domestic and foreign, including those relating to the environment and the release of greenhouse gases, such as the Environmental Protection Agency’s recently promulgated emissions regulations for coal-fired power plants, mining, miner health and safety, hydraulic fracturing, and health care; deregulation of the electric utility industry or the effects of any adverse change in the coal industry, electric utility industry, or general economic conditions; investors’ and other stakeholders’ increasing attention to environmental, social, and governance matters; liquidity constraints, including those resulting from any future unavailability of financing; customer bankruptcies, cancellations or breaches to existing contracts, or other failures to perform; customer delays, failure to take coal under contracts or defaults in making payments; our productivity levels and margins earned on our coal sales; disruptions to oil & gas exploration and production operations at the properties in which we hold mineral interests; changes in equipment, raw material, service or labor costs or availability, including due to inflationary pressures; changes in our ability to recruit, hire and maintain labor; our ability to maintain satisfactory relations with our employees; increases in labor costs including costs of health insurance and taxes resulting from the Affordable Care Act, adverse changes in work rules, or cash payments or projections associated with workers’ compensation claims; increases in transportation costs and risk of transportation delays or interruptions; operational interruptions due to geologic, permitting, labor, weather, supply chain shortage of equipment or mine supplies, or other factors; risks associated with major mine-related accidents, mine fires, mine floods or other interruptions; results of litigation, including claims not yet asserted; foreign currency fluctuations that could adversely affect the competitiveness of our coal abroad; difficulty maintaining our surety bonds for mine reclamation as well as workers’ compensation and black lung benefits; difficulty in making accurate assumptions and projections regarding post-mine reclamation as well as pension, black lung benefits, and other post-retirement benefit liabilities; uncertainties in estimating and replacing our coal mineral reserves and resources; uncertainties in estimating and replacing our oil & gas reserves; uncertainties in the amount of oil & gas production due to the level of drilling and completion activity by the operators of our oil & gas properties; uncertainties in the future of the electric vehicle industry and the market for EV charging stations; the impact of current and potential changes to federal or state tax rules and regulations, including a loss or reduction of benefits from certain tax deductions and credits; difficulty obtaining commercial property insurance, and risks associated with our participation in the commercial insurance property program; evolving cybersecurity risks, such as those involving unauthorized access, denial-of-service attacks, malicious software, data privacy breaches by employees, insiders or others with authorized access, cyber or phishing attacks, ransomware, malware, social engineering, physical breaches, or other actions; and difficulty in making accurate assumptions and projections regarding future revenues and costs associated with equity investments in companies we do not control.

Additional information concerning these, and other factors can be found in ARLP’s public periodic filings with the SEC, including ARLP’s Annual Report on Form 10-K for the year ended December 31, 2023, filed on February 23, 2024, and ARLP’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, filed on May 9, 2024. Except as required by applicable securities laws, ARLP does not intend to update its forward-looking statements.

View Full Release Here.

Investor Relations Contact
Cary P. Marshall
Senior Vice President and Chief Financial Officer
918-295-7673
investorrelations@arlp.com

Source: Alliance Resource Partners, L.P.

The Rise of Chinese E-commerce Giants and Their Impact on US Tech Earnings

Key Points:
– Temu and Shein’s rapid growth in the US market is influencing tech earnings and competition.
– These platforms leverage low prices and aggressive marketing strategies to gain market share.
– The impact of Chinese e-commerce companies on US tech giants raises questions about fair competition and trade policies.

In recent months, the e-commerce landscape in the United States has been dramatically altered by the meteoric rise of Chinese discount shopping apps Temu and Shein. As Wall Street prepares for the latest round of tech earnings reports, the influence of these platforms on industry giants like Amazon, Meta, and eBay is becoming increasingly apparent.

Temu and Shein have captured the attention of American consumers with their rock-bottom prices and aggressive marketing campaigns. Temu, which launched in the US in 2022, quickly surpassed established social media apps in popularity on the Apple App Store. Shein, present in the US market since 2017, has seen similar success. Both platforms offer incredibly low-priced goods, such as $3 shoes or $15 smartwatches, directly from Chinese manufacturers to American consumers.

The success of these platforms is partially attributed to a trade loophole known as the de minimis exception. This rule allows packages valued under $800 to enter the US duty-free, giving Chinese retailers a significant competitive advantage. Amazon’s top public policy executive, David Zapolsky, has expressed concern about this trend, suggesting that some business models may be unfairly subsidized.

The impact of Temu and Shein extends beyond just e-commerce. Their substantial ad spending has become a significant revenue source for companies like Google and Facebook. However, recent data suggests that Temu may be adjusting its marketing strategy, potentially affecting ad revenue for these tech giants.

Established e-commerce players are responding to this new competition in various ways. Amazon, while emphasizing its delivery speed advantage, is reportedly planning to launch its own discount store featuring unbranded items priced below $20. eBay has stressed its differentiated selection, while Etsy has highlighted its focus on artisan goods.

The rise of these Chinese platforms has also sparked discussions about fair competition and trade policies. US officials, along with their counterparts in the European Union, are considering closing the de minimis loophole, which could significantly impact the growth of Temu and Shein.

Despite the challenges posed by these new entrants, analysts suggest that major players like Amazon and Walmart are relatively insulated from the competition. The established e-commerce giants’ superior shipping speeds and extensive logistics networks provide a significant competitive advantage.

As the tech industry braces for the upcoming earnings reports, all eyes will be on how companies address the impact of Temu and Shein. Investors will be particularly interested in any commentary on changes in e-commerce marketplaces and shifts in ad spending patterns.

The story of Temu and Shein’s rise in the US market is more than just a tale of successful market entry. It represents a shifting dynamic in global e-commerce, raising important questions about international trade policies, fair competition, and the future of retail. As these Chinese platforms continue to grow and evolve, their impact on the US tech industry and broader economy will likely remain a topic of intense scrutiny and debate.

Release – ZyVersa Therapeutics Announces Published Data Demonstrating That Plasma Levels of Inflammasome ASC Show Promise as Biomarker of Early Cognitive Changes in Older Adults

Research News and Market Data on ZVSA

Jul 29, 2024

PDF Version

  • This data supports the potential of plasma ASC levels as a biomarker for early stages of cognitive decline, based on elevated ASC levels in older adults (>60 years) who were cognitively normal at baseline but demonstrated cognitive decline one year later (NI) compared to ASC levels in those who:
    1. Were cognitively normal at both baseline and 1 year later (NN), and
    2. Were cognitively impaired at both baseline and one year later (II)
  • Inflammasome-induced neuroinflammation has been associated with early stages of cognitive decline in dementia associated with Alzheimer’s and Parkinson’s diseases.
  • Excessive inflammasome activation leads to cell death (pyroptosis) and systemic release of cell contents, including ASC that can be measured in the plasma.

WESTON, Fla., July 29, 2024 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces that leading inflammasome researchers from the University of Miami Miller School of Medicine and inventors of Inflammasome ASC Inhibitor IC 100 have published a scientific paper in the peer-reviewed International Journal of Molecular Sciences demonstrating that plasma levels of inflammasome ASC show promise as a biomarker of early cognitive decline in older adults.

“Elevations in plasma ASC in early cognitive decline reinforce the role of inflammasome-induced inflammation in the development of neurodegenerative conditions such as Alzheimer’s and Parkinson’s diseases,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “ZyVersa is developing Inflammasome ASC Inhibitor IC 100 to inhibit multiple types of inflammasomes and their associated ASC specks that trigger damaging inflammation pathogenic in neurological and other inflammatory diseases, such as obesity and its metabolic complications, our lead indication.”

The paper titled, The Inflammasome Adaptor Protein ASC in Plasma as a Biomarker of Early Cognitive Changes, summarizes biomarker assessments in older adults at baseline and at one-year follow-up. Following is a summary of key findings:

  • Plasma ASC levels were elevated in older adults (>60 years) who were cognitively normal at baseline but demonstrated cognitive decline one year later (NI) compared to ASC levels in those who remained cognitively normal one-year post-baseline assessment (NN). The increase in ASC levels was even higher in people who were 70 years or older.
  • Likewise, plasma ASC levels in the NI group were elevated compared to ASC levels in older adults who demonstrated cognitive impairment at both baseline and one year later (II), indicating that plasma ASC levels are increased in the early stages of cognitive decline. Again, the increase in ASC levels was even higher in people who were 70 years or older.
  • In the group over 70 years old, area under the curve (AUC) for plasma levels of ASC in group Nversus group NN was 0.81, indicating excellent ability to differentiate between people with cognitive decline at one year versus those who were cognitively normal both at baseline and at one year. AUC is used to determine the diagnostic power of a biomarker.

“Dementia affects 57 million people worldwide, and the incidence is expected to double by 2040. There is an unmet need to develop minimally invasive, reliable biomarkers to diagnose early brain impairments so that emerging interventions can be applied before brain degeneration,” said Dr. Juan Pablo de Rivero Vaccari, Associate Professor of Neurological Surgery and The Miami Project to Cure Paralysis and Distinguished Faculty of the Center for Cognitive Neuroscience and Aging at the University of Miami Miller School of Medicine. “Our data indicate that plasma levels of ASC are a strong early indicator of the eventual development of cognitive impairment, especially in persons older than 70 years.”

About Inflammasome ASC Inhibitor IC 100

IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 was designed to attenuate both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, and Pyrin. Intracellularly, IC 100 binds to ASC monomers, inhibiting inflammasome formation, thereby blocking activation of IL-1β early in the inflammatory cascade. IC 100 also binds to ASC in ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1β and the perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, also attenuates the adaptive immune response. The lead indication for IC 100 is obesity and its associated metabolic complications. To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.

About ZyVersa Therapeutics, Inc.

ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced proprietary technologies to develop first-in-class drugs for patients with inflammatory or kidney diseases with high unmet medical needs. We are well positioned in the rapidly emerging inflammasome space with a highly differentiated monoclonal antibody, Inflammasome ASC Inhibitor IC 100, and in kidney disease with phase 2 Cholesterol Efflux MediatorTM VAR 200. The lead indication for IC 100 is obesity and its associated metabolic complications, and for VAR 200, focal segmental glomerulosclerosis (FSGS). Each therapeutic area offers a “pipeline within a product,” with potential for numerous indications. The total accessible market is over $100 billion. For more information, please visit www.zyversa.com.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.

New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.

Corporate, Media, and IR Contact:
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641